Clinical Trial

ONSD as an ICP Marker in vNOTES and TLH

Completed
View on ClinicalTrials.gov →
Summary
Patients undergoing conventional total laparoscopic hysterectomy (TLH) are typically placed in the Trendelenburg position with intraabdominal carbon dioxide (CO₂) insufflation. These factors may contribute to intraoperative complications such as lymphedema, impaired pulmonary function, and increased intracranial pressure. Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES), a novel minimally invasive technique, provides retroperitoneal or transperitoneal access through the vaginal route and offers the potential for shorter operative times and lower intraabdominal pressure requirements. This study aims to evaluate whether the vNOTES technique can reduce intraoperative and postoperative complications compared with TLH. Particular attention will be given to hemodynamic parameters and changes in optic nerve sheath diameter as an indirect indicator of intracranial pressure.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-11-18; most recent amendment 2026-01-05.
Status change: Recruiting → Completed 2026-01-05
Status change: Not Yet Recruiting → Recruiting 2025-11-27
Trial Details
NCT Number NCT07250178
Lead Sponsor Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Conditions Endometrial Cancer, Abnormal Uterine Bleeding, Myoma;Uterus
Enrollment 66 participants
Start Date 2025-11-27
Primary Completion 2026-01-02 (estimated)
Study Completion 2026-01-05 (estimated)
Updated on ClinicalTrials.gov 2026-01-07